Laws exist for compound cure

Friday

Mar 8, 2013 at 6:00 AM

By Charles Chieppo

Government reaction to 45 deaths and nearly 700 being sickened from contaminated injectable medications from Framingham’s New England Compounding Center has been as sadly predictable as the original event was tragic. With the horse long gone from the barn, public officials are pursuing new remedies. But the outbreak was a result of state and federal governments’ failure to enforce existing laws and regulations.

The tragedy has resulted in heightened scrutiny for compounding pharmacies and calls, as voiced by legislation filed in November by U.S. Rep. Ed Markey of Massachusetts, to dramatically expand federal oversight of compounders.

Compounding pharmacies work directly with prescribers to create customized medications for patients whose needs can’t be met by off-the-shelf medicines.

The problem is that NECC apparently wasn’t acting as a compounder last fall when its products killed or harmed people in 20 states, and state and federal agencies had reason to know the company was an accident waiting to happen.

Both state and federal authorities can inspect compounding pharmacies at any time and pull the pharmacies’ licenses if they deem it necessary.

NECC’s run-ins with the federal Food and Drug Administration and the Massachusetts Board of Pharmacy date back a decade and include previous failures to maintain adequate safeguards for sterile injectables, the direct cause of the deadly fungal meningitis outbreak.

The FDA conducted three inspections in response to complaints about NECC and issued a warning to the company in 2006.

The Massachusetts Board of Pharmacy had even more dealings with NECC. Since 2002, the board investigated 12 complaints, issued at least four advisory letters and/or formal reprimands, and entered into a 2006 consent decree with the company.

Though licensed as a compounder, it appears that NECC was acting as a manufacturer, producing large batches of drugs and selling them around the country. But the company never registered as a producer, probably because drug manufacturers, appropriately, are subject to more stringent government regulation.

In short, both state and federal authorities had every reason to know what NECC was doing and the power to pull the company’s license, but they never acted.

Rep. Markey’s bill would give the FDA a bigger role in the oversight of compounding pharmacies. But, as demonstrated by the NECC disaster, the agency lacks the resources or is otherwise unable to oversee the areas for which it’s already responsible. The legislation might make some feel better, but it would have little or no impact.

It’s no surprise that recent state inspections of 37 Massachusetts compounding pharmacies found only four in complete compliance with industry safety standards. By freely admitting that its policy had been only to inspect upon opening or when a pharmacy expands, the commonwealth had not exactly created an incentive for strict compliance. Thankfully, most of the violations found were minor and none approached what was going on at NECC.

Four people were fired in the wake of the meningitis outbreak, and state officials say they will inspect more frequently going forward. Gov. Deval Patrick’s budget proposal includes $1 million to fund much-needed inspections. A mechanism under which inspections were funded out of fees on the pharmacy industry was ended years ago.

Massachusetts and the federal government already have the tools to prevent a repeat of the NECC tragedy. The commonwealth is one of 17 states to adopt nationally accepted safety guidelines for compounding pharmacies, and even more stringent federal regulation is in place for drug manufacturers.

It’s easy to appear proactive by proposing more laws once tragedy has struck. But, as in this case, governments would often produce far better results by doing the harder work of enforcing laws and regulations that are already on the books.

Charles Chieppo is the principal of Chieppo Strategies LLC, a public policy writing and advocacy firm.